April 21, 2011

University Medical Centers COI Policies and Innovation: Talk the Talk but Not Walk The Walk

A small, but vocal group of critics has attempted to dismantle and stigmatize physician-industry relationships for a number of years. In fact, many of these individuals make their careers writing “scholarly” articles about the potential conflicts of interest (COI) in such relationships and professing themselves experts in this area of ethics in medicine.

Despite critics belief that industry-physician collaboration may create bias, the “overwhelming evidence that relationships between universities, physicians and the medical products industry benefit patients explains the ubiquitous calls to encourage such relationships.” Unfortunately however, “accumulating ‘conflict of interest’ regulations in academic health centers, government and industry have had the opposite effect,” scaring away such collaboration and in doing so, stifling innovation.

Consequently, as Lance K. Stell, PhD, professor of philosophy at Davidson College, and Thomas P. Stossel, professor of medicine at Harvard Medical School and director of translational medicine at Brigham and Women’s Hospital, pointed out in a recent commentary in Nature Medicine, “justifications underlying the regulations lack quantitative rigor, and the rules they enforce impose costly bureaucratic requirements of dubious benefit.” Moreover, evidence shows that these COI regulations “have diminished the collaborations deemed beneficial to health enhancement.”

As a result, Drs. Stell and Stossel noted that, “every policy governing the relationships between academic medical centers and the medical products industry ‘talks the talk’, forthrightly affirming that these relationships are essential for drug and device innovation.” However, they recognize that, “product innovation is in serious trouble when the same academic institutions profess to defend industry-physician collaboration while apologetically genuflecting to a COI regulation movement, the effect of which has been to suppress such collaborations.”

History of COI Movement

What is problematic about the current physician-industry collaboration atmosphere we live in today, according to the authors, is that we ignored warnings from nearly twenty years ago about “a new McCarthyism” in relation to COI policy. Yet, instead of listening to this warning from Kenneth Rothman and rising to fight it, “we invited onto our campuses moralizing avatars dedicated to purging them of corruption, the seeds of which were supposedly sown by industry’s insidious exploitation of the freedom of association and of speech.”

Accordingly, “their white-glove inspections found traces of conflict in doctor’s pockets, on their desks, in their sample cabinets, in their food, in the programs of their professional meetings—everywhere.” And instead “of critically evaluating and rebutting their allegations, chagrined, doctors acquiesced to round after round of prophylactic COI regulations, each iteration more intrusive than the last, delineating what must not be said, what types of association must not occur and what hard-earned rewards for excellence cannot be accepted by researchers and educators in our most prestigious halls of medical learning.”

Even more troublesome is that doctors are “still apologizing for these relationships,” when “the vast majority of these relationships have been free of corruption and, more importantly, have produced value for patients.” Drs. Stell and Stossel noted that without doctors working with industry to translate their ideas into useful products, today, Americans would not have a vaccine to prevent hepatitis B, a major cause of cancer worldwide, and percutaneous catheters, which enable physicians to gain access to diverse organs for diagnostic and therapeutic procedures with great speed and minimal morbidity.

Where is the Evidence?

Drs. Stell and Stossel assert that, “insinuations of corruption by those who call for increased oversight and regulation of the interaction between academia and industry require quantitative evidence—for a start, providing a denominator as well as a numerator.”

While many critics can easily compose the numerator by mentioning “the same cases alleging corruption due to industry influence, many laced with hindsight wisdom, dredged up repeatedly and assembled into a narrative framework,” a denominator is almost always missing. In fact, “the storytelling suffers from serious ‘denominator neglect’—the non-nefarious, noncorrupt, beneficial collaborations, over decades that dwarf the comparatively few cases that populate the numerator.”

As the authors point out, “when attending to the numerator, the misconduct rate is negligible. The numerator of supposedly substantive adverse outcomes due to industry relationships (excluding relationship disclosure lapses discussed below) barely adds up to two digits. Surveys reporting that over 90% of physicians have some type of financial interaction with industry, with 18% of them engaged in consulting arrangements, indicate that the denominator is orders of magnitude greater.”

Moreover, Drs. Stell and Stossel assert that, “the laundry list of adverse consequences of commercial relationships consistently invoked by COI policy framers— degraded research, neglect of teaching commitments, excessive secrecy, loss of public trust—has not materialized.” In addition, they recognized that, “speculation that commercial support of education inflicts undue bias, leading some universities to reject such support, is belied by extensive surveys reporting little impression of such bias.”

Another problem with the COI movement is their “jaundiced eye on failures to disclose payments from industry.” Critics “put stock in the marketing of a need for greater transparency—‘sunshine is the best disinfectant’. However, this seemingly plausible mission is not so straightforward; its outcome measures are not defined, nor is its price considered.”

This presents a problem for physician-industry collaboration because the ‘sunshine’ afforded to the COI movement—now federally mandated as part of the Patient Protection and Affordable Care Act—will have a substantial impact on innovation. While this expensive effort is intended to help the public to make informed judgments about whether their healthcare providers have been compromised, are biased or likely to be disloyal, “the data cannot reliably support such inferences.”

The reality is this data will not show the public what innovation is. It will not explain to Americans that, “innovation is not academic research” and that, “academic institutions, especially elite ones, are incompatible with the mass-production and quality-control requirements of product development.” Nevertheless, what this data should show the public is that “academia and industry have much to offer one another—if given the chance.”

And what Americans must realize is that this chance for academia and industry to collaborate and innovate, “requires a lot of trial and error to accommodate the unpredictability of biology and adaptation to serendipity associated with innovation.” As a result, “requiring minute oversight and contractual specification of every interaction and staples of COI regulations are inimical to such flexibility.”

Innovation

Outside of collaboration, Drs. Stell and Stossel also emphasized that clinicians can only help patients if they know about innovative products. However, the COI movement derides “industry marketing as qualitatively different from and morally inferior to academic education, which stigmatizes “practically useful information (and academic health centers market their services aggressively with far less regulation than industry).” “Worse, banning such marketing from campuses drives a care-impairing wedge between producers of drugs and devices and prescribing physicians.”

“The COI movement insinuates that industry cares only about returns on investments and nothing about the appropriate use of their products, a charge not only disrespectful but wrong. The COI movement perpetuates the prejudice that the medical products and academic medical industries inhabit separate moral universes: the former unprincipled and greedy, the latter altruistic and dedicated solely to science and service. The evidence is to the contrary: research misconduct has been more common in academic settings where workers are subject to far less oversight than in the medical products industry.”

Accordingly, Drs. Stell and Stossel assert that, “demanding regulation of COI represents a pejorative, framing bias. No party to any relationship wears the same hat at the same time and in the same way; no relationship aligns hat-wearing incentives perfectly. Physicians wear many hats, and industry workers do, too. Myriad descriptions characterize the complex, nuanced relationships between academic physicians and workers in the medical products industry. To impress onto this complexity and, by fiat, the taint of ethical toxicity requires strong justification.”

However, the COI movement has no strong justification. Instead, they stamp all physician-industry relationships with “arbitrary bias, insinuating that physicians’ relationships with industry need toxicity management—eliminate, reduce, minimize or disclose, rather than proliferate, increase and maximize.” Drs. Stell and Stossel “challenge the linguistic legerdemain that substitutes ethically suspect for mutually beneficial.”

Discussion

The “poisonous language” from the COI movement “has promoted damaging policies in academic health centers in some states and in the federal government. The damage is not merely rhetorical. It has discouraged academic-industry collaboration because both parties fear media opprobrium. Worse, burdensome compliance requirements burn precious resources that would better go to collaboration, research and education.” Additionally, industry itself is also facing barriers to collaboration “thanks to the exploitation of COI rhetoric by prosecutors in league with whistleblowers, maladaptive US Food and Drug Administration (FDA) law and draconian penalties (i.e. debarment).

Drs. Stell and Stossel note that, “patients desperate for new and better treatments should be appalled—we all should be appalled.” They noted that, “abandoning this desultory course requires that our academic leaders return to walking the walk.

Rather than shrinking before poorly justified, slogan-ridden allegations of critics, sensation-seeking media and demagogue politicians, they should subject them to the same rigorous analysis they demand from their scientific endeavors.” This analysis “will steer them to recommitting their institutions to collaboration and cooperation with their industry partners.”

Ultimately, such changes are necessary because Americans expect “excellence in research, education, and patient care,” and physicians “should pursue [these goals] with no apologies.”